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The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.

The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series.

In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options;

• a) "SoftFix™ Balloon Fixation Ring" combination
• b) "SoftFix™ Balloon Fixation Cone" combination

Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.

The provided text is a 510(k) Summary for the SoftFix™ Balloon Trocar. It describes non-clinical performance testing but does not contain information about acceptance criteria or studies related to AI/algorithm performance, human reader studies, ground truth establishment, or training set details. Therefore, many of the requested items cannot be answered from the provided document.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for any of the individual non-clinical tests. It only states that "non-clinical testing were conducted."
• There is no information on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This document describes non-clinical performance testing for a medical device (trocar), not an AI/imaging diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation (e.g., radiologists) is not applicable. The ground truth for these physical and functional tests would be based on engineering specifications and direct measurements against those specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/imaging diagnostic device requiring human adjudication of interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device (trocar), not an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the ground truth is based on predefined engineering specifications, industry standards (ISO), and mechanical measurements/simulations.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical medical device.

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The Unimax Laparoscopic Instrument is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.

The Unimax Laparoscopic Instrument includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.

The provided text describes a 510(k) summary for the Unimax Laparoscopic Instrument, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance acceptance criteria for an AI device.

Therefore, many of the requested items (e.g., sample sizes for test sets and training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance) are not applicable to this document as it pertains to a traditional medical device (surgical instruments) and not an AI/ML-driven device.

However, I can extract the relevant information regarding performance testing and acceptance criteria for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the comparative performance testing included the items listed below and that "All the test results demonstrate the performance of Unimax Laparoscopic Instrument meets the requirements of its pre-defined acceptance criteria and intended uses." Specific numerical acceptance criteria are not detailed in this summary. Instead, it relies on demonstrating equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

Not applicable. This is not an AI/ML device study. The testing was physical and mechanical bench testing, as well as biocompatibility and electrical safety. The document does not specify sample sizes for these tests, nor data provenance in terms of country of origin of data or retrospective/prospective study, as these concepts are generally tied to clinical data or AI model development.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device that requires experts to establish ground truth from clinical images or data. The "ground truth" here is the performance metrics defined by engineering standards and industry best practices for surgical instruments.

4. Adjudication method for the test set

Not applicable. No expert adjudication method (like 2+1, 3+1) is mentioned or relevant for the type of bench testing conducted for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a traditional laparoscopic instrument, not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. There is no algorithm or AI component in this device, so standalone algorithm performance testing is not relevant.

7. The type of ground truth used

For the physical, mechanical, electrical safety, and biocompatibility tests, the "ground truth" is defined by adherence to recognized international standards and engineering specifications (e.g., IEC 60601 series, ISO 10993 series, ISO 11135-1) and comparison with the predicate device's established performance. It's not clinical "outcomes data" or "pathology" in the typical sense for AI devices, but rather objective measurements and compliance with regulatory and engineering benchmarks.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML model.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML training set for this device.

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The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.

The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.

The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.

The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.

The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.

The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.

The Unimax Trocar System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes used for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage). The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, although it can be inferred that the testing was conducted by or for Unimax Medical Systems Inc., a company located in Taiwan. These were non-clinical bench tests performed on the device itself.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable. The Unimax Trocar System is a physical medical device, and the "ground truth" for its performance is established through objective engineering and safety tests rather than expert interpretation of medical images or clinical outcomes that would require expert consensus.

4. Adjudication Method for Test Set

This information is not applicable for a physical device undergoing performance and safety bench testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image analysis) to resolve discrepancies among multiple expert readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices or AI-assisted systems where human reader performance is being evaluated with and without AI assistance. The Unimax Trocar System is a surgical instrument.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The document explicitly states: "A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System." And "The performance testing conducted on subject device and predicate device are listed below: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage." The conclusion states, "After analyzing bench tests, safety testing data, it can be concluded that: Unimax Trocar System is as safe and effective as the predicate device."

7. Type of Ground Truth Used

The ground truth for the performance of the Unimax Trocar System was established through objective measurements and observation during non-clinical bench testing for physical characteristics (e.g., fit, stability, leakage) and through adherence to recognized international standards for biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).

8. Sample Size for Training Set

This information is not applicable. The Unimax Trocar System is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as there is no training set for this device.

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The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.

The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.

The provided text describes a 510(k) premarket notification for the "Unimax Anti-Fog Solution." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving new acceptance criteria for an AI device. Therefore, the requested information about AI device acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance is not available in the given text.

The document states that a series of safety and effectiveness tests were performed to assess the Unimax Anti-Fog Solution. The results of these tests demonstrate that the device meets its predefined acceptance criteria and intended uses.

1. A table of acceptance criteria and the reported device performance

The document mentions that all test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses. However, it does not explicitly list the acceptance criteria or specific performance values for the fog resistance test, cleaning ability test, extractable test, or prolonged fog resistance test. It only states that the results indicate the new device is "as safe and effective as the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document as it refers to a medical device's physical properties, not an AI model requiring ground truth from experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. This is not an AI device. The tests performed are laboratory standard tests.

8. The sample size for the training set

This information is not provided in the document. This is not an AI device and does not involve training sets.

9. How the ground truth for the training set was established

This information is not provided in the document. This is not an AI device and does not involve training sets.

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The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

The Unimax Veress Needle is not an AI/ML device, but rather a traditional medical device (a surgical instrument). Therefore, the provided document does not contain the information typically associated with AI/ML device evaluations, such as studies on algorithm performance, human-in-the-loop performance, ground truth establishment for training/test sets, or sample sizes related to AI model development.

The document describes the non-clinical testing performed to demonstrate the safety and effectiveness of the Unimax Veress Needle and its substantial equivalence to a predicate device.

Here's the information extracted from the document based on the provided categories, with "N/A" for criteria not applicable to a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes (e.g., number of needles tested for each physical/mechanical test) or the exact provenance of the data (e.g., where the in vivo tests were conducted). It is indicated that the manufacturer is based in Taipei, Taiwan. The tests are non-clinical (preclinical), not clinical data, and appear to be prospective testing of the device itself rather than data collection from a population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This is a non-AI/ML device. Ground truth, in the context of AI, refers to expert-labeled data. For a physical medical device, performance is evaluated against engineering specifications and international standards, not against expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI ground truth. For this device, performance is measured against technical specifications and standard compliance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a non-AI/ML device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a non-AI/ML device. "Standalone performance" refers to the performance of an AI algorithm without human involvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this medical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (e.g., ISO 10993 series, ISO 11135-1) and demonstrating performance at least equivalent to the predicate device through physical and mechanical testing (e.g., Tip Pull Test, Switch Operation, Spring Obturator Operation, Needle Puncture Force Test). There is no "ground truth" in the AI sense for this type of product.

8. The sample size for the training set

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

9. How the ground truth for the training set was established

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

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The Unimax Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The Unimax Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.

The suction irrigation set consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.

The Unimax Suction Irrigation Set is a medical device used for suction and irrigation during laparoscopic surgery. The 510(k) summary indicates that non-clinical testing was performed to assess its safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests." However, it does not specify the sample size for the test sets (e.g., how many devices were tested for each specific non-clinical test) or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing described appears to be primarily bench/laboratory testing and biocompatibility assessments, which typically do not involve expert ground truth establishment in the same way clinical imaging or diagnostic AI studies would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. The described tests are laboratory-based and do not involve human adjudication of results in the context of diagnostic performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable and not provided. The device is a physical surgical instrument (suction irrigation set), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable and not provided. The device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" would be established by pre-defined technical specifications, engineering standards (e.g., IEC 60601-2-2), and regulatory requirements for device performance and safety (e.g., fluid flow rates, suction power, material strength, biocompatibility standards). For biocompatibility, the ground truth is the biological response observed in standardized tests against accepted thresholds.

8. The sample size for the training set:

This is not applicable and not provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established:

This is not applicable and not provided for the same reason as point 8.

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The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.

This is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance and studies are not applicable.

Here's an analysis of the provided text regarding the Unimax Specimen Retrieval System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K103510) is a 510(k) premarket notification for a medical device. For such devices, acceptance criteria are typically established through a series of non-clinical tests to demonstrate safety and effectiveness. The document refers to "pre-defined acceptance criteria" but does not explicitly list these criteria or their specific values. Instead, it states that the device "meets the requirements of its pre-defined acceptance criteria."

The performance is described relative to a predicate device (Applied Medical Resources Corporation Specimen Retrieval System, K100959), asserting "substantial equivalence."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes used for these test sets. The data provenance is generally "bench testing" and "in vitro and in vivo preclinical tests," which are types of lab or animal studies, not human clinical trial data. There's no indication of country of origin for the internal testing data, but the submitter's address is in Taipei, Taiwan. The studies were prospective in the sense that they were conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For non-clinical tests on a medical device like this, ground truth is typically established against engineering specifications, material standards, and biological safety standards (like ISO 10993). It is not usually established by human expert consensus in the way it would be for an AI diagnostic tool.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and objective, based on measurements against predefined criteria and standards rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI image analysis or diagnostic tools, not for a physical specimen retrieval system. Therefore, an effect size of human improvement with AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, a standalone algorithm study was not done. This device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests (physical, mechanical, biocompatibility) would be based on established engineering specifications, material science standards, and accepted biological safety standards (e.g., ISO 10993). For instance, a tensile strength test would have a pre-defined ground truth for the minimum acceptable strength. Biocompatibility would be evaluated against the absence of adverse biological reactions as defined by ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

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